MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0186
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/22/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
This product has not been returned; therefore, a technical analysis cannot be conducted.Without a returned product it is not possible to definitively confirm how this product may have contributed to the complaint incident.Following return and completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that during a competitor normal device change out and upgrade procedure, the physician elected to replace this boston scientific lead due to rising thresholds and pacing impedance measurements however, no values were reported out of range at the time of the procedure.During this surgical undertaking, the physician encountered superior vena cava (svc) adhesions which ruptured during the extraction portion of the procedure.Additional surgical intervention was immediately performed due to tamponade induced blood loss.The patient passed away as a result of the procedure.The lead was extracted in fragments and is expected to be returned for analysis.
Event or Problem Description
It was reported that during a competitor normal device change out and upgrade procedure, the physician elected to replace this boston scientific lead due to rising thresholds and pacing impedance measurements however, no values were reported out of range at the time of the procedure.During this surgical undertaking, the physician encountered superior vena cava (svc) adhesions which ruptured during the extraction portion of the procedure.Additional surgical intervention was immediately performed due to tamponade induced blood loss.The patient passed away as a result of the procedure.The lead was extracted in fragments and returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Laboratory technicians identified the lead severed into three segments.The distal shocking coil and lead tip were missing in what appeared to have been forcibly pulled apart and fractured.Both of the middle segments exhibited significant conductor and insulations explant damages.Based upon the observed calcification on the proximal shocking electrode (which would imply calcification to also have existed on the non returned, lead tip) high capture threshold and high impedance allegations were confirmed; such deposits are known to contribute to an increase in lead impedances.Testing was completed to assess the leads electrical performance.Measurements throughout these tests were within normal limits and setscrew markings were noted on the terminal pin and in the correct location.Vessel perforation and the patient death were unable to be linked to the returned product analysis.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11307337
• Report Number: 2124215-2021-03407
• Device Sequence Number: 3711467
• Product Code: LWS
• UDI-Device Identifier: 00802526531200
• UDI-Public: 00802526531200
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/18/2008
• Device Model Number: 0186
• Device Catalogue Number: 0186
• Device Lot Number: 101892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 44 YR